A South African trial by researchers at the department of global health, University of Washington in Seattle finds 90% of people receiving rapid viral load testing were virally suppressed and in care after 12 months, compared to 76% who waited for tests. The randomised control trial involved 390 adults living with HIV attending a public clinic in Durban, South Africa between February and August 2017 who had been on antiretroviral treatment (ART) for six months.
At the beginning of the study, half of the participants received standard, laboratory-based viral load testing, carried out by professional nurses and had to wait around 28 days for their results. The other half underwent rapid viral load testing with task-shifting to ‘enrolled nurses’ and had their results the same day. In South Africa, enrolled nurses receive two years of training while professional nurses train for four.
Viral load testing was conducted again six months later. After 12 months, 90% of people in the intervention group stayed in care and were virally suppressed, meaning levels of HIV in their blood were so low they were undetectable, and they were likely to be in good health. By comparison, 76% of people in the control group were retained in care and virally suppressed.
Looking at these two factors separately, a 10% higher rate of viral suppression and an 8% higher rate of retention in care were observed in the intervention group compared to the control group.
These improved treatment outcomes were linked to a number of factors. Firstly, people in the intervention group were able to begin adherence counselling straight away if their viral load test results indicated a need. The intervention also improved the time it took to detect total treatment failure by 68 days.
Treatment failure was detected among seven (4%) participants in the intervention group and nine (5%) in the control group. All those in the intervention group were switched to an alternative ART regimen and most were switched quickly; three on the same day, and two within one week. By comparison, less than half (44%) of those in the control group experiencing treatment failure were switched to an alternative ART regimen and this took a median of 76 days.
For those on effective treatment, same-day viral load testing helped to speed up access to community-based ART, which is often more convenient for patients and less expensive to deliver. People were eligible for this if they had a suppressed viral load after six months of being in the study, which was 12 months after they had begun taking ART. Overall, 116 (56%) people in the intervention group and 52 (27%) in the standard-care group were referred to community-based ART. The referral time for those in the intervention group was 168 days compared to 261 days for those in the control group.
Because the trial had two factors – point-of-care testing and task shifting to enrolled nurses – the extent by which each contributed to improving treatment outcomes remains unclear. However, the results demonstrate that rapid viral load testing can speed up the delivery of viral load results, which in turn can enable more people living with HIV to become virally suppressed, meaning they are less likely to become ill, develop drug resistant HIV, or transmit HIV to others.
Abstract
Background: Monitoring HIV treatment with laboratory testing introduces delays for providing appropriate care in resource-limited settings. The aim of our study was to determine whether point-of-care HIV viral load testing with task shifting changed treatment and care outcomes for adults on antiretroviral therapy (ART) when compared with standard laboratory viral load testing.
Methods: We did an open-label, non-inferiority, randomised controlled trial in a public clinic in Durban, South Africa. We enrolled HIV-positive adults (aged ≥18 years) who presented for their first routine HIV viral load test 6 months after ART initiation. Individuals were randomly assigned by a random number allocation sequence to receive either point-of-care viral load testing at enrolment and after 6 months with task shifting to enrolled nurses (intervention group), or laboratory viral load testing (standard-of-care group). The primary outcome was combined viral suppression (<200 copies per mL) and retention at 12 months after enrolment. A non-inferiority margin of 10% was used. Analysis was done by intention to treat. This study was registered with ClinicalTrials.gov, NCT03066128.
Findings: Between Feb 24, 2017, and Aug 23, 2017, we screened 657 participants, and 390 were enrolled and randomly assigned to either the intervention group (n=195) or standard-of-care group (n=195). 175 (90%) individuals in the intervention group and 148 (76%) individuals in the standard-of-care group had the primary outcome of retention with viral suppression, a difference of 13·9% (95% CI 6·4–21·2; p<0·00040). 182 participants (93%) in the intervention group had viral suppression compared with 162 (83%) in the standard-of-care group (difference 10·3%, 3·9–16·8; p=0·0025); 180 (92%) and 162 (85%) were retained in care (7·7%, 1·3–14·2; p=0·026). There were no adverse events related to point-of-care HIV viral load testing or task shifting.
Interpretation: Point-of-care viral load testing combined with task shifting significantly improved viral suppression and retention in HIV care. Point-of-care testing can simplify treatment and improve outcomes for HIV-positive adults receiving ART in resource-limited settings.
Funding: National Institute of Allergy and Infectious Diseases.
Authors
Paul K Drain, Jienchi Dorward, Lauren R Violette, Justice Quame-Amaglo, Katherine K Thomas, Natasha Samsunder, Hope Ngobese, Koleka Mlisana, Pravikrishnen Moodley, Deborah Donnell, Ruanne V Barnabas, Kogieleum Naidoo, Salim S Abdool Karim, Connie Celum, Nigel Garrett
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[link url="https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018%2819%2930402-3/fulltext"]The Lancet abstract[/link]